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NCT04024943 · ClinicalTrials.gov registry record

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

A clinical trial of Heart Failure, sponsored by Medtronic.

Active
Registry status
1,092
Enrollment target
20
Study locations

NCT04024943 is a study of Heart Failure that is active but no longer recruiting, run by Medtronic. The registered enrollment target is 1,092 participants, below the 2,046-participant average among 397 other Heart Failure trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT04024943, a study of Heart Failure, is active but no longer recruiting, sponsored by Medtronic.

ACTIVE NOT RECRUITING
Registry status
1,092 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

Conditions Studied

Interventions

  • DEVICE Quadripolar LV Lead

Study Locations (20)

Florida

  • Clearwater Cardiovascular Consultants - Clearwater
  • Heart Rhythm Solutions - Hollywood
  • Baptist Health - Jacksonville
  • Cardiovascular Institute of Northwest Florida - Panama City
  • Heart & Vascular Institute of Florida - Safety Harbor
  • Heart Rhythm Consultants P.A. (Sarasota Memorial Research) - Sarasota

California

  • Chula Vista Cardiac Center - Chula Vista
  • San Diego Arrhythmia Associates - San Diego
  • COR Healthcare - Torrance
  • Cardiovascular Consultants Medical Group (Van Nuys) - Van Nuys
  • Cardiology Associates Medical Group - Ventura

Colorado

  • Colorado Springs Cardiology - Colorado Springs
  • Denver Heart - Denver
  • Colorado Heart and Vascular - Lakewood

Arkansas

  • Cardiology Associates of Northeast Arkansas - Jonesboro
  • Saint Vincent Heart Clinic Arkansas - Little Rock

Connecticut

  • Hartford Hospital - Hartford
  • Yale New Haven Hospital - New Haven

Alaska

  • Alaska Heart - Anchorage

Arizona

  • Southwest EP - Chandler

Trial Details

FieldValue
Enrollment Target 1,092 participants
Start Date 2017-08-21
Est. Completion 2028-01

Sponsor

Medtronic

30 total trials

What the Registry Record Tells You About NCT04024943

The ClinicalTrials.gov registry entry for NCT04024943 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 1,092 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,046-participant average among 397 other Heart Failure trials with a reported enrollment target (47% lower). The listed sponsor is Medtronic, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Quadripolar LV Lead is the first listed.

NCT04024943 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04024943 about?

NCT04024943 is a clinical study titled "Personalized Therapy Study - Attain Stability Quad Post-Approval Study". The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV...

What is the current status of trial NCT04024943?

This trial is currently active not recruiting. The enrollment target is 1,092 participants. The study started on 2017-08-21. Estimated completion is 2028-01.

What conditions does trial NCT04024943 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT04024943?

The interventions under investigation include: Quadripolar LV Lead (DEVICE).

Who is sponsoring clinical trial NCT04024943?

This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04024943 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.